Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

The general aim of this research is to gain insight in the role of SSCT in the etiology and progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and biomechanical characteristics. This eventually may lead to damage of the median nerve. To examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used First, the reliability of the US technique to characterize morphology of the SSCT will be investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS patients to provide descriptive parameters and to describe differences between patients and controls. In the final part a prospective study will be conducted to look at changes of SSCT thickness over time and after treatment.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For CTS patients
Human adults, 18 years and older
Complaints compatible with CTS (Katz Hand Diagram[31] rating of 'classic', 'probable' or 'possible' or typical clinical signs)
Indication for electrodiagnostic testing
Informed consent to participate
For Healthy subjects
Human adults, 18 years and older
Negative electrodiagnostic testing and scoring 'unlikely' at Katz Hand diagram
Informed consent to participate

Exclusion criteria

Pregnancy
History of renal disease, diabetes, chemotherapy, tumors, other neurological diseases (e.g., polyneuropathy), thyroid disease
Problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout, tendinopathy at the wrist, acute trauma of the upper limb

Treatment and study plan

SSCT thickness measurement

Diagnostic Test

Thickness measurement with ultrasound

Primary outcomes

Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound

Time frame: baseline

To determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.
Baseline subsynovial connective tissue thickness

Time frame: Baseline

To determine correlations between SSCT thickness and participant characteristics (e.g., age, gender) in patients with carpal tunnel syndrome and healthy subjects. To obtain normative data for SSCT thickness in healthy subjects and patients with carpal tunnel syndrome.
Change in subsynovial connective tissue thickness after 3, 6 and 12 months

Time frame: 3, 6, 12 months

To evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).
Change in subsynovial connective tissue thickness after treatment

Time frame: 3, 6, 12 months

To evaluate the effect of treatment (i.e., surgery or infiltration) on SSCT thickness in patients with carpal tunnel syndrome. Orthopedic surgeon decides independently if and which treatment is necessary for the patient. If possible, to subgroup patients according to the correlation between their response to treatment, assessed with electrodiagnostic testing and clinical variables, and (change in) SSCT thickness.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Jul 29, 2020
Registry last updated: Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed